MAUDE Adverse Event Report: VENTLAB VENTLAB HYPERINBLATION BAG SYSTEM; AMBU BAG / RESUSCITATOR BAG

Model Number AF1000

Device Problem Torn Material (3024)

Patient Problems Hypoxia (1918); Respiratory Distress (2045); Brain Injury (2219)

Event Date 11/02/2015

Event Type  Injury  

Event Description

Critical care team responded to transfer pt to icu related to respiratory distress.Respiratory therapist unable to intubate.So began to use ambu bag.Respiratory therapist states something happened to flap on ambu bag rendering it useless.Pt placed on bipap while a nurse went to obtain another ambu bag.Pt continued to drop in oxygen saturation, so began to use ambu bag and flap tore again.Pt eventually was intubated, but declared pt suffered hypoxic brain injury.

• Brand Name: VENTLAB HYPERINBLATION BAG SYSTEM
• Type of Device: AMBU BAG / RESUSCITATOR BAG
• Manufacturer (Section D): VENTLAB; 2701 northridge dr.; nw ste a; grandrapids MI 49544
• MDR Report Key: 5347419
• MDR Text Key: 35242133
• Report Number: MW5058908
• Device Sequence Number: 1
• Product Code: BTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF1000

Device Catalogue Number

Device Lot Number

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 55 YR
• Patient Weight: 92